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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93520

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 22, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DeRoyal Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

Z-0622-2024
Recall number
Z-0622-2024
Initiated
November 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
252 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

Code information

GTIN 00749756364065, Serial Numbers: '59716839, '59867186

Distribution pattern

US: Virginia